• ReconRecon

    Recon: Pfizer asks FDA to okay storing vaccine at higher temps; J&J seeks WHO emergency listing for COVID vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer wants to store vaccine at higher temperatures, making distribution easier ( Reuters ) Pfizer plans to test COVID-19 vaccine booster targeting the South African variant ( Reuters ) CDC data on first month of vaccinations find Pfizer-BioNTech, Moderna shots safe to use ( Reuters ) Biden to visit Pfizer factory as Americans clamor for more COVID-19 vaccine...
  • ReconRecon

    Recon: Eli Lilly, Rigel in $960 autoimmune tie-up; New WTO chief calls to end COVID export restrictions

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Researchers urge delaying Pfizer vaccine's second dose as first highly effective ( Reuters ) ( NEJM ) Eli Lilly in deal with Rigel to develop autoimmune therapy for up to $960 million ( Reuters ) Johnson & Johnson has only a few million COVID-19 vaccine doses in stock as likely launch nears ( Reuters ) ( CNBC ) CDC Announces $200 Million ‘Down Payment’ to Trac...
  • ReconRecon

    Recon: EU reaches deals for additional Pfizer, Moderna shots; Medtronic recalls unused Valiant Navion stents

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Insiders at Covid-19 Vaccine Makers Sold Nearly $500 Million of Stock Last Year ( WSJ ) After a controversial Alzheimer’s drug review, FDA’s Woodcock rejects proposal to ‘firewall’ agency review staff ( STAT ) ( Endpoints ) Biden Administration Says It Has Increased Vaccine Supply ( NPR ) Biden admin rushes to close virus-sequencing gap as variants spread ( Po...
  • ReconRecon

    Recon: Australia provisionally authorizes AstraZeneca vaccine; BMS, Sanofi ordered to pay Hawaii $834M over Plavix warning label

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna expects to supply second 100 million vaccine doses to US by May-end ( Reuters ) Low vaccine supply pushes US vaccination timeline to at least late May: Fauci ( Reuters ) Bristol-Myers, Sanofi ordered to pay Hawaii $834M over Plavix warning label ( Reuters ) ( STAT ) Bluebird suspends studies of sickle cell gene therapy following cancer diagnoses in two...
  • ReconRecon

    Recon: FDA approves Regeneron antibody for rare cholesterol disorder; EMA says kidney problems not related to remdesivir

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Agrees Moderna Can Increase Vaccine Supply in Each Vial ( NYTimes ) As Millions Get Shots, FDA Struggles to Get Safety Monitoring System Running ( NYTimes ) Biden administration finalizes purchase of 200M additional vaccine doses ( Politico ) ( NPR ) ( NYTimes ) Biden says there will not be enough COVID vaccines by end of summer to vaccinate all Americans ...
  • ReconRecon

    Recon: Novo’s semaglutide shows promise for weight loss in Phase III trial; EU nears deal with Novavax

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Merck in talks with governments, other drugmakers to produce COVID-19 shots ( Reuters ) How Merck, a Vaccine Titan, Lost the Covid Race ( NYTimes ) Can’t Find an N95 Mask? This Company Has 30 Million That It Can’t Sell. ( NYTimes ) OWS: Accelerated COVID-19 Vaccine Development Status and Efforts to Address Manufacturing Challenges ( GAO ) Biden admin asks SCO...
  • Regulatory NewsRegulatory News

    Recon: FDA issues EUA for Lilly antibody combo; Federal court tosses ‘skinny labeling’ decision

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Gilead’s Galapagos deal falls apart, a black mark for CEO O’Day ( STAT ) ( Endpoints ) ( Reuters ) Eli Lilly's antibody combination receives FDA EUA for COVID-19 ( Reuters ) ( Endpoints ) ( FDA ) FDA panel admonishes Merck with a gentle — and rare — slapdown for rushing its pitch on an accelerated OK for adjuvant Keytruda in TNBC ( Endpoints ) ( Pink Sheet ) T...
  • ReconRecon

    Recon: EU orders additional 300M doses of Pfizer-BioNTech vaccine; France steps up aid to boost pharma manufacturing

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Joe Biden’s big FDA decision ( Vox ) ( Politico ) Woodcock vs. Sharfstein: A head-to-head comparison of Biden’s top choices for FDA commissioner ( STAT ) Eli Lilly says CFO resigns after 'inappropriate communication' with staff ( NBC ) ( Endpoints ) Democratic lawmakers push FDA to lift restrictions on abortion pill ( Politico ) Democrats push temporary Obama...
  • ReconRecon

    Recon: China approves Sinovac vaccine for general public; Pfizer expects to speed vaccine production

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer expects to cut COVID-19 vaccine production time by close to 50% as production ramps up, efficiencies increase ( USA Today ) ( Fierce ) Fauci looking ahead to more vaccines in March, April ( Politico ) Virus Variant First Found in Britain Now Spreading Rapidly in US ( NYTimes ) White House says it is working to speed early production of J&J COVID-19 vacc...
  • ReconRecon

    Recon: Pfizer withdraws application for COVID vaccine in India; AstraZeneca’s Imfinzi fails in head and neck cancer trial

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden health team hatches new vaccine strategy as variant threat builds ( Politico ) ( Reuters ) J&J files COVID-19 vaccine application with FDA ( Reuters ) ( Politico ) AstraZeneca expects US trial results in next 4-6 weeks, research chief says ( Reuters ) Op-Ed: The right leader for the FDA in a time of crisis ( LA Times ) Merck warns against using anti-par...
  • ReconRecon

    Recon: McKinsey settles opioid claims for $573M; UK to study Pfizer, AstraZeneca COVID vaccine combo

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Opioid crisis haunts frontrunner for top job at US drugs regulator ( FT v) Merck chief Kenneth Frazier to retire this summer ( FT ) ( STAT ) ( CNBC ) After a Rocky Start, Novavax Vaccine Could Be Here by Summer ( NYTimes v) 55.9 million doses of COVID-19 vaccines distributed, 33.8 million administered: U.S. CDC ( Reuters ) Merck anti-baldness drug Propecia ha...
  • ReconRecon

    Recon: Jazz to buy GW Pharma for $7.2B; GSK, CureVac partner on vaccine for COVID variants

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden and Drug Makers Look to Speed Coronavirus Vaccine Deliveries ( NYTimes ) Biden administration to begin shipping vaccine doses directly to pharmacies ( Politico ) States in the US are Pulling Back Vaccine Doses from Federal Program for Nursing Homes ( NYTimes ) Vaxart shares plunge 60% on concern that lackluster antibody response will hinder effectiveness...